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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 11, 2021
The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.
January 02, 2021
Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.
EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.
Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.
December 31, 2020
FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.
Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.
December 15, 2020
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.
December 14, 2020
Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.
December 11, 2020
The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.
December 08, 2020
The product is being recalled because of Burkholderia cepecia contamination.